In the pharmaceutical space, much has been written about the challenges some drug product manufacturers and contract packaging/contract manufacturing organizations face in readying for the Nov. 2017 DSCSA deadline.
That’s not the case for outsourcing services provider PCI Pharma Services (PCI), whose latest expansion in serialization capacity triples its global supply network to support clients in advance of meeting both U.S. DSCSA and E.U. FMD implementation dates.
PCI has been actively serializing commercial products for both domestic and international markets for the past five years, with products destined for North America and Europe, in addition to emerging market geographies such as South Korea, Turkey, Brazil, China and others. In total, PCI supports medicines destined to more than 100 global countries.
The company has partnered with Antares Vision, Marchesini and Domino for this latest installation, utilizing Antares’ serialization platform and technology architecture across a variety of serialization technology platforms and applications. Xyntek Inc., the exclusive U.S. partner and turnkey solution provider of Antares Vision, is helping PCI with the planning, coordination, design, integration, and installations of the serialization solutions across its U.S. sites. The multi‐site installations support a variety of drug delivery forms, including bottles, unit cartons and parenteral kits, as well as unit-dose wallets and child-resistant/compliance-prompting packaging.
Serialization technologies support ancillary and tertiary packaging, corrugated shippers and palletization solutions for supporting multi‐level product aggregation. Aggregation is technically not a requirement for compliance to the 2017 DSCSA deadline, however PCI has strongly supported the advanced use of aggregation to realize significant benefits in packaging operations as well as the broader pharmaceutical supply chain.
PCI Vice President of Global Engineering, Ken Richardson, says, “Serialization preparedness is the topic on everyone’s mind in the pharmaceutical industry. We are very excited about the next phase of our global serialization initiative and brand security program here at PCI. Having active developed and supported serialization over the past five years with numerous commercial applications around the world, we have a significant body of knowledge to share with clients.
“With these key learnings from practical applications of serialization and anti‐counterfeiting technologies, we have positioned ourselves to support our clients as they start to truly develop their own global serialization strategies. This latest investment is considerable, and features what we believe are truly industry‐leading technologies. The spotlight is on the industry to meet the November deadline and PCI has directed an amazing amount of financial resource, technological expertise and manpower to help our clients be prepared.”
PCI’s announcement of its recent serialization expansion complements an announcement in late 2016 of its investment in site capacity expansion for its commercial contract packaging services. PCI sites in Philadelphia and Rockford added multiple primary packaging lines including blister packaging, bottling, and pouch/sachet filling technologies as demand continues to grow for outsourced packaging services.
During the past 18 months PCI has hosted regional Serialization Forums in geographical pharmaceutical concentrations including Philadelphia, Boston, Research Triangle Park (RTP) North Carolina, Chicago/Rockford, San
Diego, San Francisco, and most recently London, drawing considerable crowds and interest. Future venues and dates will be announced in the coming months and interested attendees are encouraged to follow PCI’s social media channels including Twitter and LinkedIn for more details.